NAD Augmentation in Diabetes Kidney Disease
A phase 2a trial randomized, double-blind, placebo-controlled, parallel group trial to determine whether NMN administration improves DKD, as indicated by a significantly greater reduction in UACR compared with placebo administration. Eligible participants will be randomized to receive either 1000 mg NMN or placebo twic
| Condition(s) | Type2diabetes, Diabetic Kidney Disease |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | A phase 2a trial randomized, double-blind, placebo-controlled, parallel group trial to determine whether NMN administration improves DKD, as indicated by a significantly greater reduction in UACR compared with placebo administration. Eligible participants will be randomized to receive either 1000 mg NMN or placebo twice daily. |
| Who can participate | Inclusion Criteria: 1. A man or a postmenopausal woman (complete cessation of menses for one or more years and /or FSH \> 20 U/L), 30 years or older 2. Has type 1 or type 2 diabetes mellitus, as indicated by any of the following: 1. Self-report of type 1 or type 2 diabetes plus the use of a prescribed medication. 2. ICD-10 code for type 1 or type 2 diabetes plus current use of a medication in the electronic medical record. 3. HbA1c \>6.4%; or 2 fasting glucose \> 125 mg/dL 3. Has an average of two or more morning UACR equal to or above 100mg/g creatinine each of which must be equal to or greater than 60 mg / g creatinine with at least one UACR value measured during the screening visit. a. Recent UACR value in the medical record within the preceding 3 months prior to screening is acceptable |
| Ages | 30 Years |
| Sex | All |
| Lead sponsor | Brigham and Women's Hospital |
| Locations | Boston, Massachusetts, United States |
| Start date | 2023-04-13 |
| NCT ID | NCT05759468 |
| Official listing | https://clinicaltrials.gov/study/NCT05759468 |